ORAGRAFIN CALCIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORAGRAFIN CALCIUM (ORAGRAFIN CALCIUM).
Oragrafin Calcium is a diagnostic radiocontrast agent that contains calcium ipodate. It acts by absorbing X-rays due to its high iodine content (61% iodine by weight). After oral administration, it is absorbed and excreted into the bile, allowing radiographic visualization of the gallbladder and biliary ducts. It may also enhance CT imaging of the liver and biliary tree.
| Metabolism | Oragrafin Calcium is not extensively metabolized; it is excreted primarily as unchanged drug in the bile and urine. A small fraction may undergo deiodination or conjugation in the liver. |
| Excretion | Primarily renal: 90% of absorbed dose excreted unchanged in urine within 24 hours; <10% via feces. Biliary excretion is negligible in the absence of hepatobiliary obstruction. |
| Half-life | Terminal elimination half-life is 1.2 hours (0.7–2.0 hours) in patients with normal renal function. May be prolonged in renal impairment (up to 18 hours in severe impairment). |
| Protein binding | Negligible (<1% bound to plasma proteins). |
| Volume of Distribution | Approximately 0.5 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral: ~6% (low systemic absorption due to poor intestinal uptake; drug acts locally in GI tract). |
| Onset of Action | Oral administration: radiographic opacification of the GI tract begins within 30 minutes; for visualization of the distal small bowel and colon, 1–3 hours. Intravenous administration is not used due to toxicity risks. |
| Duration of Action | Oral: adequate visualization persists for 4–6 hours. In patients with delayed transit, visualization may extend up to 8 hours. Note: not for parenteral use; intravascular injection can cause severe circulatory reactions. |
Oral: 5 mL (1 packet) orally, may repeat in 30-60 minutes if needed. Maximum 2 doses per procedure. Rectal: 100-200 mL of a 1:1 dilution with water as a retention enema.
| Dosage form | GRANULE |
| Renal impairment | No specific dose adjustment required; use with caution in severe renal impairment (eGFR <30 mL/min/1.73 m²) due to risk of contrast-induced nephropathy. Consider alternative imaging if GFR <30. |
| Liver impairment | No specific dose adjustment recommended for Child-Pugh class A, B, or C. Use with caution in severe hepatic impairment due to potential alterations in bile acid metabolism. |
| Pediatric use | Neonates and infants: 1-2 mL/kg orally as a single dose. Children: 2.5-10 mL orally based on age (2-5 years: 2.5-5 mL; 6-12 years: 5-10 mL). Maximum 10 mL per dose. |
| Geriatric use | No specific dose adjustment; use lower end of dosing range (5 mL orally) due to increased risk of dehydration and contrast-induced nephropathy. Ensure adequate hydration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ORAGRAFIN CALCIUM (ORAGRAFIN CALCIUM).
| Breastfeeding | Limited data; iodinated contrast agents are excreted in breast milk in low amounts. M/P ratio unknown. The American College of Radiology recommends no interruption of breastfeeding following administration, but consider potential for infant hypothyroidism. |
| Teratogenic Risk | FDA Pregnancy Category D. First trimester: theoretical risk of fetal hypothyroidism from iodide exposure, avoid unless essential. Second and third trimesters: fetal thyroid suppression and goiter formation possible; use only if clearly needed with fetal thyroid monitoring. |
■ FDA Black Box Warning
No FDA black box warning is currently associated with Oragrafin Calcium.
| Serious Effects |
["Known hypersensitivity to ipodate or any component of the formulation","Severe renal impairment (e.g., anuria, oliguria)","Acute or chronic thyroid disease (e.g., thyrotoxicosis)","Severe hepatic impairment with impaired biliary excretion","Concurrent administration with oral cholecystographic agents containing tyropanoate or iopanoic acid (may cause renal toxicity)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Renal impairment: Use with caution in patients with pre-existing renal disease or dehydration; risk of contrast-induced nephropathy","Thyroid dysfunction: Iodinated contrast can induce hyperthyroidism or hypothyroidism, especially in patients with underlying thyroid disease","Hepatic impairment: Use with caution in severe hepatic disease as excretion may be altered","Pregnancy: Category C; use only if clearly needed and benefits outweigh risks"] |
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| Fetal Monitoring |
| Monitor maternal thyroid function before and after administration. Fetal ultrasound to assess for goiter and thyroid function. Monitor for signs of neonatal hypothyroidism post-delivery. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies not reported. However, high iodine intake can disrupt thyroid function, potentially affecting ovulation; clinical relevance unclear. |